Tibial insert having a keel including a bore formed therein

ABSTRACT

A tibial insert includes a platform defining an upper bearing surface and a bottom surface. A keel of the tibial insert is coupled to the bottom surface of the platform and includes a bore extending along a width of the keel. The bore is formed to receive a fastener therein.

CROSS-REFERENCE TO RELATED APPLICATIONS

Cross-reference is made to U.S. patent application Ser. No. 11/171,802titled TIBIAL INSERT AND ASSOCIATED SURGICAL METHOD, which was filed onJun. 30, 2005 by James Matthew Rhodes and Jordan Soonja Lee, wasassigned to the same assignee as the present application, and is herebyincorporated by reference herein. Cross-reference is further made toU.S. patent application Ser. No. 11/425,936 entitled TIBIAL INSERT ANDMETHOD FOR IMPLANTING THE SAME by James Matthew Rhodes and Jordan SoonjaLee; U.S. patent application Ser. No. 11/425,921 entitled TIBIAL INSERTHAVING MULTIPLE KEELS by James Matthew Rhodes and Jordan Soonja Lee; andU.S. patent application Ser. No. 11/425,929 entitled TIBIAL INSERTHAVING A REINFORCED KEEL by James Matthew Rhodes and Jordan Soonja Lee,each of which is assigned to the same assignee as the presentapplication, each of which is filed concurrently herewith, and each ofwhich is hereby incorporated by reference.

FIELD OF THE DISCLOSURE

The present disclosure relates generally to orthopaedic prostheses, andparticularly to tibial inserts and the keel portion of the tibialinsert.

BACKGROUND

During the lifetime of a patient, it may be necessary to perform a jointreplacement procedure on the patient as a result of, for example,disease or trauma. For example, many knee replacement surgeries areperformed each year. Total knee replacement or arthroplasty may involvereplacement of the mid-shaft portion of the femur, proximal, distal,and/or total femur, and proximal tibia. Unicompartmental kneereplacement or arthroplasty involves unicondylar resurfacing.Unicompartmental knee arthroplasty provides an alternative to total kneearthroplasty for rehabilitating knees when only one condyle has beendamaged as a result of trauma or disease such as noninflammatorydegenerate joint disease or its composite diagnosis of osteoarthritis orpost-traumatic arthritis, for example. As such, unicompartmental kneearthroplasty may be indicated for use in patients undergoing surgery fora severely painful and/or disabled joint damaged as a result ofosteoarthritis, traumatic arthritis, rheumatoid arthritis, or a failedprevious implant when only one condyle of the knee (medial or lateral)is affected. Further, unicompartmental knee replacements may be“multi-piece” replacements wherein a unicompartmental tibial insert isused to replace each of the medial and lateral condyles of the patient.A single, total femoral component or two partial femoral components maybe used to cooperate with the two unicompartment inserts.

Unicompartmental knee replacements are intended to provide increasedpatient mobility and reduce pain by replacing the damaged knee jointarticulation in patients where there is evidence of sufficient soundbone to seat and support the components. Age and activity level factorinto all reconstructive procedures and the state of the arthritisdetermines the treatment. With the advancement of minimally invasivetechniques that support unicompartmental knee reconstruction, a growingnumber of patients are offered this alternative for relief from thedisabling pain of arthritis and for the potential benefits of a rapidrecovery. Many technical challenges persist, however, with respect toproviding less invasive unicompartmental knee surgeries.

SUMMARY

According to one aspect of the present disclosure, a tibial insertincludes a platform having an upper bearing surface and a plurality ofkeels extending downwardly from the platform. Illustratively, none ofthe longitudinal axes of the keels are parallel to an axis running alongan inboard surface of the platform. Further, the longitudinal axis ofone of keels may be parallel to the longitudinal axis of another of thekeels. Alternatively, the longitudinal axis of one of the keels mayintersect the longitudinal axis of another of the keels. Further, theseintersecting axes may be orthogonal to each other.

Further illustratively, the plurality of keels defines a total keelvolume. A medial portion of the total keel volume, which is located on amedial side of the tibial insert, may be different from (i.e., greaterthan or less than) a lateral portion of the total keel volume, which islocated on a lateral side of the tibial insert.

The plurality of keels may include a first keel and a second keel.Additionally, the plurality of keels may further include a third keel.

The longitudinal axis of each of the keels may be parallel to a bottomsurface of the platform and each of the plurality of keels may besubstantially the same length. Further, the longitudinal axes of theplurality of keels may not be coaligned with each other.

According to yet another aspect of the present disclosure, a surgicalmethod for knee arthroplasty includes determining the quality of thebone of various sections of a patient's resected tibia, selecting atibial insert having a keel arrangement which corresponds to areas ofpoor quality of the patient's resected tibia, forming one or more slotsin a surgically-prepared surface of the resected tibia which correspondto the keel arrangement of the selected tibial insert, and inserting thekeel arrangement of the tibial insert into the one or more slots.

Illustratively, the tibial insert may be selected from a plurality oftibial inserts having different keel arrangements.

Further illustratively, the one or more slots may be formed in the areasof poor bone quality of the patient's resected tibia.

Additionally, the quality of the bone of various sections of thepatient's resected tibia may be determined by placing a template ontothe surgically-prepared surface of the resected tibia and pressing aprobe into portions of the surgically-prepared surface. The surgicalmethod may further include marking the bone through cut-out portions ofthe template to indicate areas of poor bone quality. Further, the one ormore slots may be formed through cut-out portions of the template whichhave been marked to indicate areas of poor bone quality.

According to still another aspect of the present disclosure, a tibialinsert includes a platform including an upper bearing surface and a keelextending downwardly from the platform. The keel is positioned relativeto the platform such that the longitudinal axis of the keel is parallelto a bottom surface of the platform and is arranged in a non-parallelrelationship relative to an inboard edge of the platform.

According to yet another aspect of the present disclosure, a tibialinsert includes a platform having an upper bearing surface and first andsecond keels extending downwardly from the platform. A longitudinal axisof the first keel is generally parallel with an inboard surface of theplatform and a longitudinal axis of the second keel is generallyparallel with the longitudinal axis of the first keel. An anterior faceof the second keel may be positioned posteriorly from an anterior faceof the first keel. A posterior face of the second keel may also bepositioned anteriorly from a posterior face of the first keel. Thesecond keel may be positioned laterally from the first keel and theanterior face of the first keel and the anterior face of the second keelmay each be angled. Illustratively, the angle of the anterior face ofthe first and second keels may be approximately 145 degrees from abottom surface of the platform. A posterior face of each of the firstand second keels may be generally vertical. Further illustratively, thefirst keel may be longer than the second keel and the second keel may bepositioned generally within a posterior portion of the tibial insert. Alongitudinal axis of the first keel may be parallel to a longitudinalaxis of the second keel. The longitudinal axes of each of the first andsecond keels may be parallel to an inboard surface of the platform.

According to yet another aspect of the present disclosure, a surgicalmethod for knee arthroplasty includes resecting at least a portion of acondyle to create a surgically-prepared, generally horizontal surface,forming a first slot in the surgically-prepared, generally horizontalsurface such that the first slot is positioned between and spaced-apartfrom an anterior surface of the tibia and a posterior surface of thetibia, forming a second slot in the surgically-prepared, generallyhorizontal surface such that the second slot is positioned between andspaced-apart from the anterior surface of the tibia and the posteriorsurface of the tibia, and inserting (i) a first keel of a tibial insertinto the first slot formed in the surgically-prepared, generallyhorizontal surface and (ii) a second keel of the tibial insert into thesecond slot formed in the surgically-prepared, generally horizontalsurface.

Illustratively, the first keel may be inserted into the first slot by(i) inserting a posterior end of the first keel into the first slot,(ii) sliding the first keel in a posterior direction such that theposterior end of the first keel engages the posterior end of the firstslot, and (iii) pivoting the tibial insert downwardly such that a secondend of the first keel is positioned within the first slot. Similarly,the second keel may be inserted into the second slot by (i) inserting aposterior end of the second keel into the second slot, (ii) sliding thesecond keel in a posterior direction such that the posterior end of thesecond keel engages the posterior end of the second slot, and (iii)pivoting the tibial insert downwardly such that a second end of thesecond keel is positioned within the second slot.

Further illustratively, the second slot may be parallel to the firstslot and may further include an anterior end that is positionedposteriorly from an anterior end of the first slot. Additionally,forming the second slot may be positioned laterally from the first slot.

According still another aspect of the present disclosure, a tibialinsert includes a platform having an upper bearing surface and a keelextending downwardly from the platform. The keel includes a lateral boreformed therein. The lateral bore may be parallel to a lateral axis ofthe keel or may be positioned to define a non-parallel relationship withthe lateral axis of the keel. Further, the lateral bore of the keel maybe generally perpendicular to the longitudinal axis of the keel.Illustratively, the keel includes a medial, downwardly-extendingsurface, a lateral, downwardly-extending surface, and a rounded, distalsurface defining a continuous radius connecting the first and seconddownwardly-extending surfaces and the lateral bore of the tibial insertextends from the medial, downwardly-extending surface of the keel to thelateral, downwardly-extending surface of the keel. Further, the lateralbore may be substantially centrally-located between a bottom surface ofthe platform and the rounded, distal surface of the keel. The lateralbore may extend entirely through the width of the keel or may extendonly partially through the width of the keel. Further, the keel of thetibial insert may include a second lateral bore formed therein.

According to yet another aspect of the present disclosure, a tibialinsert assembly includes a tibial insert having (i) a platform includingan upper bearing surface and (ii) a keel extending downwardly from theplatform and including a lateral bore formed therethrough. The assemblyfurther includes a fastener configured to be received through thelateral bore of the tibial insert after the tibial insert is implantedin a patient's tibia. The tibial insert of the assembly may furtherinclude a second lateral bore formed through the keel. As such, thetibial insert assembly may further include a second fastener configuredto be received through the second lateral bore after the tibial insertis implanted in a patient's tibia.

According to still another aspect of the present disclosure, a surgicalmethod for knee arthroplasty includes resecting at least a portion of acondyle to create a surgically-prepared, generally horizontal surface,forming a slot in the surgically-prepared, horizontal surface, insertinga keel of a tibial insert into the slot, and inserting a fastener in amedial-lateral direction through keel.

The keel may include a bore through a width of the keel such that thefastener may be inserted through the bore of the keel. Further, apassageway may be drilled from a medial surface of the tibia in alateral direction through the tibia to intersect the slot formed in thesurgically-prepared, generally horizontal surface. The fastener may thenbe inserted into the passageway and through the lateral bore of thekeel. The passageway formed in the tibia may be filled with cement.Drilling the passageway may be performed prior to inserting the keel ofthe tibial insert into the slot or may be performed after inserting thekeel of the tibial insert into the slot.

According to yet another aspect of the present disclosure, a method ofmanufacturing a tibial insert includes inserting a rod into a lateralbore formed in the tibial insert and applying a surface treatment to anouter surface of the tibial insert when the rod is positioned in thelateral bore. The surface treatment may be applied by (i) engaging therod with a mechanical handler to avoid touching the tibial insert and(ii) removing the rod from the lateral bore of the tibial insert afterapplying the surface treatment to the outer surface of the tibialinsert. A second rod may also be inserted into a second lateral bore ofthe tibial insert.

According to still another aspect of the present disclosure, a tibialinsert includes a platform having an upper bearing surface, a keelextending downwardly from the platform, and a rod spaced-apart from theplatform and positioned to extend through a portion of the keel.Illustratively, the keel and the platform may be made from a firstmaterial and the rod may be made from a second material. Furtherillustratively, the keel and the platform may be made from a polymer andthe rod may be made from a metal.

The rod may be positioned along the length of the keel or along thewidth of the keel or may include a first rod positioned along the lengthof the keel and a second rod positioned along the width of the keel. Thefirst rod and the second rod may intersect each other. Illustratively,the longitudinal axis of the keel and the longitudinal axis of the rodmay be positioned along an anterior-posterior direction.

The keel may include an anterior face and a posterior face such that afirst end of the rod is generally planar with the anterior face of thekeel and a second end of the rod is positioned within the keel and isspaced-apart from the posterior face of the keel.

The rod may be solid or the rod may be hollow to define an outer shelland an inner passageway. Illustratively, the keel may further includeinterior passageways in fluid communication with the inner passageway ofsuch a hollow rod. The keel may further include a channel defined in anouter surface of the keel. This channel may be in fluid communicationwith the interior passageways of the keel. The hollow rod may includeapertures formed in the outer shell to provide fluid communicationbetween the inner passageway of the hollow rod and the interior channelsof the keel.

According to another aspect of the present disclosure, a tibial insertincludes a platform having an upper bearing surface, a keel extendingdownwardly from the platform, and a rod positioned within at least aportion of the keel such that longitudinal axis of the rod is parallelto the longitudinal axis of the keel. Illustratively, the keel may belonger than the rod or may be generally the same length as the rod.

According to still another aspect of the present disclosure, a surgicalmethod for knee arthroplasty includes resecting at least a portion of acondyle of a patient's tibia to create a surgically-prepared tibialsurface, positioning a tibial insert on the surgically-prepared tibialsurface, and injecting bone cement into a passageway formed through arod positioned within the keel of the tibial insert. The bone cement maybe injected through the passageway and into a space defined between anouter surface of the keel and a portion of the patient's tibia.Alternatively, the space may be defined by a channel formed in an outersurface of the keel. Additionally, the bone cement may be forced throughinterior passageways of the keel which fluidly connect the passageway ofthe rod with the channel of the keel.

The above and other features of the present disclosure will becomeapparent from the following description and the attached drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The detailed description particularly refers to the accompanying figuresin which:

FIG. 1 is a perspective view of a unicompartmental tibial insert showinga keel of the insert and a solid reinforcement rod extending along ananterior-posterior length of the keel;

FIG. 2 is a sectional view of the tibial insert of FIG. 1;

FIG. 3 is a sectional view of another unicompartmental tibial insertshowing a first solid reinforcement rod extending along theanterior-posterior length of the keel and a second solid reinforcementrod extending along a medial-lateral width of the keel;

FIG. 4 is a sectional view taken through the second reinforcement rod ofthe tibial insert of FIG. 3;

FIG. 5 is a perspective view of yet another unicompartmental tibialinsert showing a hollow reinforcement rod extending along theanterior-posterior length of the keel;

FIG. 6 is a sectional view of the tibial insert of FIG. 5 showinginternal channels of the keel in fluid communication with aperturesformed in the hollow reinforcement rod;

FIG. 7 is a sectional view of the tibial insert of FIGS. 5 and 6positioned within a slot formed in a patient's tibia and showing bonecement having been injected into the hollow reinforcement rod to fillthe passageway of the rod, the internal channels of the keel, and theexternal groves of the keel;

FIG. 8 is a side perspective view of another unicompartmental tibialinsert showing a keel of the insert including first and secondmedial-lateral bores formed through a medial-lateral width of the keel;

FIG. 9 is a bottom perspective view of the tibial insert of FIG. 8showing first and second rods received through the first and secondbores;

FIG. 10 is a sectional view of the tibial insert of FIG. 8 positionedwithin a slot formed in a patient's tibia showing the first rod havingbeen inserted into the patient's tibia and through the firstmedial-lateral bore of the keel to secure the tibial insert to thepatient's tibia;

FIG. 11 is a bottom perspective view of another unicompartmental tibialinsert having three keels;

FIG. 12 is a bottom perspective view of another unicompartmental tibialinsert having three keels oriented in a manner different than that shownin FIG. 11;

FIG. 13 is a bottom perspective view of another unicompartmental tibialinsert having two substantially parallel keels;

FIG. 14 is a bottom perspective view of another unicompartmental tibialinsert having two substantially orthogonal keels;

FIG. 15 is a bottom perspective view of another unicompartmental tibialinsert having two keels, each keel having an angled anterior face;

FIGS. 16-18 are side perspective views of the tibial insert of FIG. 15being inserted into two slots formed in the patient's tibia;

FIG. 19 is a side perspective view of the tibial insert of FIGS. 15-18fully inserted within the slots formed in the patient's tibia.

FIG. 20 is a perspective view of a template device which may be usedduring a knee replacement surgery to aid a surgeon in identifying areasof poor bone quality; and

FIG. 21 is a perspective view of another template device.

DETAILED DESCRIPTION OF THE DRAWINGS

While the concepts of the present disclosure are susceptible to variousmodifications and alternative forms, specific exemplary embodimentsthereof have been shown by way of example in the drawings and willherein be described in detail. It should be understood, however, thatthere is no intent to limit the disclosure to the particular formsdisclosed, but on the contrary, the intention is to cover allmodifications, equivalents, and alternatives following within the spiritand scope of the invention as defined by the appended claims.

As shown in FIGS. 1 and 2, a tibial insert 10 includes a platform 12 anda keel 16 extending downwardly from the platform 12. Illustratively, thetibial insert 10 is a unicompartmental tibial insert intended to replaceonly one of the two bearing surfaces of an illustrative tibia 22, asshown in FIG. 7, for example. As such, the tibial insert 10 may be usedby a surgeon or other technician during a unicompartmental kneearthroplasty (UKA). Illustratively, the insert 10 as well as othertibial inserts disclosed herein are suitable for use or implantation bysurgeons adopting either conventional or minimally invasive surgicalmethods of performing UKA. Further, although the tibial insert 10 is aunicompartmental tibial insert, it is within the scope of thisdisclosure that the various features associated with the tibial insert10, as well as other tibial inserts discussed, may also be associatedwith tibial inserts typically used during total knee arthroplasty (TKA)to replace both bearing surfaces of the tibia. Further still, it iswithin the scope of this disclosure for the various features associatedwith the many tibial insert embodiments disclosed herein to beassociated with other types of orthopaedic implants such as orthopaedicimplants associated with hips, shoulders, and elbows, for example.

Looking again to FIGS. 1 and 2, the platform 12 is generally “D-shaped”when viewed in a plan view and includes an upper bearing surface 14, alower surface 18, a curved, outer or outboard surface 19, and agenerally straight inner or inboard surface 21. The keel 16 extends fromthe bottom surface 18 of the platform 16. As is defined herein, the term“keel” means a structure extending downwardly from the bottom surface ofthe platform for insertion into a portion of a patient's bone during anorthopaedic joint arthroplasty procedure, with such a structure (i)having a longitudinal axis that is arranged generally parallel to aplane defined by the bottom surface of the platform, (ii) lacking radialsymmetry along its longitudinal axis, and (iii) has a ratio between afirst length, L1, measured along the distal-most edge of the structureand a second length, L2, measured along the edge of the structure whichis formed with or abuts the bottom surface of the platform of between0.15-1.0.

Hence, a keel is distinct from a peg which generally includes alongitudinal axis perpendicular to the plane defined by the bottomsurface of the platform of the tibial insert. Further, a peg isoftentimes radially symmetrical along its longitudinal axis. Moreover, akeel is distinct from a fin which typically extends downwardly from theplatform to a tip or point thus defining a first length measured alongthe distal-most edge of the fin which is less than 15% the length of theedge of the fin which abuts the bottom surface of the platform. As such,a keel as used herein is distinct from both pegs and fins of tibialinserts.

As described above, a ratio between the length, L1, measured along thedistal-most edge of the keel 16 and the length, L2, measured along theedge of the keel 16 which is formed with or abuts the bottom surface ofthe platform is between 0.15-1.0. In other words, the length L1 isbetween 15%-100% of the length L2. In some embodiments, the length L1may be between 20%-80% of the length L2 while in other embodiments, thelength L1 may be between 20%-60% of the length L2. In still otherembodiments, the length L1 may be between 20-40% of the length L2.

Illustratively, the longitudinal axis 15 of the keel 16 of the tibialinsert 10 extends in an anterior-posterior direction between an anterior(or front) side 24 of the tibial insert 10 and a posterior (or back)side 26 of the tibial insert. Further, the lateral axis 13 of the keel16 extends in a medial-lateral direction, as shown in FIG. 4. The keel16 is dimensioned such that its anterior-posterior length (L1 and/or L2)is greater than its height H. Illustratively, the height H of the keel16 is measured from the bottom surface 18 of the platform 12 to thedistal-most edge of the keel 16 as shown in FIGS. 2 and 4. In otherwords, the height H of the keel is the distance which the keel extendsdownwardly from the bottom surface 18 of the platform 12 in theinferior-superior direction. The keel 16 is also longer than it is wide.In particular, the length (L1 and/or L2) of the keel 16 is greater thanthe width W of the keel 16.

Illustratively, the cross-section of the keel 16 is generally“U-shaped”, and, as such, has an outer, curved wall 132. Specifically,the keel 16 includes a rounded distal end which defines a generallysemi-circular shape in cross-section. In other words, a portion of thekeel 16, and specifically the distal end of the keel 16, forms ordefines a 180° arc. As such, the keel includes a generallydownwardly-extending medial surface 140, a generallydownwardly-extending lateral surface 142, and a rounded, distal surface144 defining a continuous radius connecting the first and seconddownwardly-extending surfaces 140, 142. Of course, it is within thescope of this disclosure to include keels having other cross-sectionalshapes or squared-off edges, for example.

The keel 16 further includes a passageway 17 extending along thelongitudinal axis 15 of the keel 16. Illustratively, the passageway 17is circular in cross-section; however, it is within the scope of thisdisclosure to include a passageway having any other suitablecross-sectional shape such as square-shaped, rectangular, andtriangular, octagonal, etc. As shown in FIG. 2, the passageway 17 is ablind hole formed in the anterior face 34 of the keel 16. That is, thepassageway 17 extends partially through the length of the keel 16 fromthe anterior face 34 of the keel 16 and terminates within the keel 16 ata point anterior to the posterior face 36 of the keel 16. However, it iswithin the scope of this disclosure to include a passageway 17 whichextends the entire length of the keel 17 (i.e., is open to both theanterior face 34 and the posterior face 36 of the keel 16).Alternatively, the passageway 17 may begin at the posterior face 36 ofthe keel 16 and terminate at some point within the keel 16 beforereaching the anterior face 34 of the keel 16. In another alternativeembodiment, the passageway 17 may be located entirely within theinterior of the keel 16 without opening to either the anterior face 34of the keel 16 or to the posterior face 36 of the keel 16.

A solid reinforcement rod 50 is positioned within the passageway 17 ofthe keel 16. The illustrative reinforcement rod 50 is circular incross-section and is substantially the same length of the passageway 17.Of course, if the cross-section of the passageway 17 is something otherthan circular, the cross-section of the reinforcement rod 50 may belikewise shaped. In other words, the reinforcement rod 50 may have asquare, rectangular, oval, triangular, octagonal, or other suchcross-sectional shape as well.

During manufacture of the tibial insert 10, the passageway 17 may bemolded or preformed in of the keel 16. Alternatively, the tibial insert10 may be molded with a solid keel, the passageway 17 being subsequentlydrilled or otherwise machined into the keel 16. In either case, once thepassageway 17 has been formed to into the keel 16, the reinforcement rod50 may then be press-fit into the passageway 17. If desired, a cement orglue may be used to secure the reinforcement rod 50 within thepassageway 17 of the keel 16. Alternatively, the polymer portions of thetibial insert 10, such as the platform 12 and the keel 16, may be insertmolded around the reinforcement rod 50.

Illustratively, the reinforcement rod 50 is solid and is made from ametal or metal alloy such as titanium, stainless steel, or cobaltchromium, for example. Of course, it is within the scope of thisdisclosure for the reinforcement rod 50 to be made from other suitablemetals as well. Further, it is within the scope of this disclosure forthe reinforcement rod 50 to be made from one or more materials otherthan metals such as polymers, ceramics, cements, glass, etc.

As noted above, the platform 12 and keel 16 are illustratively made froma polymer such as UHMWPE (ultra high molecular weight polyethylene) forexample. However, the keel 16 and the platform 12 may be made from othermaterials suitable for implantation into the human body. Thereinforcement rod 50 is harder and/or more rigid than the polymermaterial from which the keel 16 is made. As such, the reinforcement rod50 increases the stiffness or rigidity of the keel 16 while stillallowing the keel 16 to possess an outer shell made from a polymermaterial.

Looking now to FIGS. 3 and 4, there is shown a tibial insert 110 that issomewhat similar to the tibial insert 10. Like reference numerals havebeen used in FIGS. 3 and 4 to designate features which are similar tothose designated in FIGS. 1 and 2. A second solid rod 150 of the tibialinsert 110 is positioned within a second passageway 117 of the keel 16and extends in the lateral direction of the keel 16 from the medialsurface 140 of the keel 16 to the lateral surface 142 of the keel 16, asshown in FIG. 3. As such, the second solid rod 150 is parallel to thelateral axis 13 of the keel 16. A groove or outer channel 160 is formedin each of the medial and lateral surfaces 140, 142 and extends alongthe length of the keel 16.

As noted above, the rod 150 of the tibial insert 110 illustrativelyextends laterally through the keel 16 from the medial surface 140 to thelateral surface 142, as shown in FIG. 4. Illustratively, the rod 150 isparallel to the lateral axis 13 of the keel 16 and intersects the rod50. As such, the rods 50, 150 may be embodied as an integral structure.Alternatively, the rod 50 may include a passageway through which the rod150 extends or the rod 150 may include a passageway through which therod 50 extends. In either case, the rods 50, 150 intersect each otherand are illustratively orthogonal to each other. That is, the rod 50includes a longitudinal axis (not shown) which co-aligns with, or isparallel to, the longitudinal axis 15 of the keel. The rod 150, includesa longitudinal axis (not shown) which extends the medial-lateraldirection and is parallel to the lateral axis 13 of the keel 16. Assuch, the longitudinal axis of the rod 50 and the longitudinal axis ofthe rod 150 are orthogonal to each other. It is within the scope of thisdisclosure, however, for the rod 150 to extend from the medial surface140 of the keel 16 to the lateral surface 142 of the keel 16 at an angleor non-parallel relationship to the lateral axis 13 of the keel 16.Similarly, the rod 50 may also extend in a non-parallel relationship tothe longitudinal axis 15 of the keel 16.

Although the passageway 117 and the rod 150 of the tibial insert 110 areeach shown to extend from the medial surface 140 of the keel 16 to thelateral surface 142 of the keel 16, it is within the scope of thisdisclosure to provide a second rod which extends only to either themedial surface 140 of the keel 16 or to the lateral surface 142 of thekeel 16. In other words, the passageway 117 may form a blind hole ineither the medial or lateral surfaces 140, 142 of the keel 16. Further,the rod 150 may be located entirely internally within the keel 16 suchthat neither end of the second rod extends to or through either of themedial or lateral surfaces 140, 142 of the keel 16.

It is also within the scope of this disclosure to position the rod 150at any point along the anterior-posterior length of the keel 16. Asshown in FIG. 4, for example, the rod 150 is generally positionedapproximately mid-way between the anterior face 34 of the keel 16 andthe posterior face 36 of the keel 16. The rod 150, however, may also bepositioned further in an anterior direction or in a posterior direction.It is also within the scope of this disclosure to include additionalreinforcing rods positioned such that their longitudinal axes aregenerally parallel to the lateral axis 13 of the keel 16. Suchmedial-lateral reinforcing rods may be evenly spaced-apart from eachother such that a first medial-lateral rod is positioned in an anteriorhalf of the keel 16 while a second medial-lateral rod is positioned in aposterior half of the keel 16, for example. In other embodiments, themedial-lateral rods may be positioned such that each resides within oneof the anterior half or posterior half of the keel 16.

Looking now to FIGS. 5-7, there is shown another tibial insert 210 thatis somewhat similar to the tibial inserts 10, 110 described above. Assuch, like reference numerals have been used in FIGS. 5-7 to designatefeatures which are similar to those designated in FIGS. 1-4. However,the tibial insert 210 includes an alternative reinforcement rod 250which is hollow or tubular and defines its own passageway 217therethrough. As is used herein, the term “rod” refers to both a solidstructure such as the solid rods 50, 150 shown in FIGS. 1-4 as well asto a hollow structure such as the hollow rod 250 shown in FIGS. 5-7. Inother words, the term “rod” includes both solid and hollow structures.

Looking again to FIGS. 5 and 6, the rod 250 includes an outer shell 252defining the inner passageway 217. Similar to the solid rods 50, 150disclosed above, the hollow rod 250 is preferably made from a metal, butmay be made from other materials as well. The hollow rod 250 includes ananterior end which is generally planar with the anterior face 34 of thekeel 16. However, as shown in FIG. 6, a posterior end of the rod 250terminates prior to reaching the posterior face 36 of the keel 16. Assuch, the posterior end of the rod 250 is located internally within thekeel 16 and the passageway 17 of the keel 16 is a blind passagewayformed in the anterior end of the keel 16, as shown in FIG. 6. It iswithin the scope of this disclosure, however, for the passageway 17 ofthe keel 16 as well as the rod 250 of the tibial insert 210 to extendthrough the length of the keel 16 from the anterior face 34 to theposterior face 36 of the keel 16. Alternatively, the rod 250 may bepositioned such that a posterior end of the rod 250 is generally planarwith the posterior face 36 of the keel 16 and an anterior end of the rod250 terminates at some point within the keel 16 before reaching theanterior face 34 of the keel 16.

The outer shell 252 of the hollow rod 250 further includes apertures 254formed therethrough. The keel 16 of the tibial insert 210 furtherincludes interior passageways 256 (shown in FIGS. 6 and 7) which extendfrom the anterior-posterior passageway 17 formed through the keel 16 toexterior channels or grooves 160 formed in each of the medial andlateral surfaces 140, 142 of the keel 16. Further illustratively, theouter shell 252 of the hollow rod 250 includes four apertures 254positioned along the length of a medial side of the rod 250 and fourother apertures 254 positioned along the length of a lateral side of therod 250. As such, the illustrative keel 16 includes four medialpassageways 256 which each extend between one of the medial apertures254 of the rod 250 and the outer channel or groove 160 formed in themedial surface 140 of the keel 16. The keel 16 further includes fourlateral passageways 256 which each extend between one of the lateralapertures 254 of the rod 250 and the outer channel or groove 160 formedin the lateral surface 142 of the keel 16. Accordingly, the passageway217 through the hollow rod 250 is in fluid communication with theinterior passageways 256 of the keel 16 via the apertures 254 and theinterior passageways 256 of the keel 16 are in fluid communication withat least one of the outer grooves 160 formed in the keel 16.

It is within the scope of this disclosure to include a hollow rod havingany number of apertures formed in the outer shell of the rod and forsuch apertures to be oriented in any configuration. Further, it iswithin the scope of this disclosure for the keel to include any numberof internal passageways in fluid communication with one or more of theapertures of the rod and in fluid communication with one or more of thegrooves formed in the medial and lateral surfaces 140, 142 of the keel16. The keel 16 and platform 12 may also include other passageways, suchas illustrative passageways 260, 262 (shown in FIG. 7) which are influid communication with the passageway 217 of the rod 250 and with, forexample, recessed portion 60 (also shown in FIG. 7) formed in the bottomsurface 18 of the tibial insert 210, for example. Such passageways 260,262 may be used to inject cement 286 into the recessed portion 60 of theinsert 210. Illustratively, passageways 260, 262 are formed in the outersurface of the keel 16 and the bottom surface 18 of the platform 12.However, one or more internal passageways as well as other such externalpassageways may be formed through portions of the tibial insert 210 inorder to fluidly connect one or more recessed portions, such as recessedportion 60, with the passageway 217 of the rod 250.

Looking now to FIG. 7, during a total or partial knee arthroplasty, aportion of a condyle of a patient's tibia 22 is resected to create asurgically-prepared, generally horizontal surface 280, asurgically-prepared, generally vertical surface 282, and a slot 284formed within a portion of the horizontal surface 280. Once the surfaces280, 282 and slot 284 have been formed, the tibial insert 210 is thenpositioned on the horizontal surgically-prepared tibial surface 280 andthe keel 16 of the tibial insert 210 is positioned within the slot 284.Bone cement 286 is injected in the passageway 217 of the hollow rod 250.As shown in FIGS. 5 and 6, the anterior end of the rod 250 is accessibleto the surgeon to allow the surgeon (or other technician) to inject bonecement 286 directly into the passageway 217. As bone cement 286 is urgedinto the passageway 217 to fill the passageway 217, the bone cement 286is also urged to exit the passageway 217 via the apertures 254 formed inthe outer shell 252 of the rod 250 and to enter the interior passageways256 of the keel 16. As additional bone cement 286 is urged into thepassageway 217, the bone cement 286 exits the interior passageways 256of the keel 16 to fill the medial and lateral grooves 160 formed in theouter surfaces 140, 142 of the keel 16. Once the bone cement 286 beingsto exit the anterior end of the slot 284 via the medial and lateralgrooves 160 of the keel 16, the surgeon is made aware that the bonecement 286 has filled the passageway 217, interior channels 256, and themedial and lateral grooves 160, and may refrain from injectingadditional bone cement 286 into the passageway 217.

While the internal passageways 256 of the keel 16 fluidly connect thepassageway 217 of the hollow rod 250 with external grooves 160 formed inthe keel 16, it is within the scope of this disclosure to include atibial insert having other interior passageways through the keel 16and/or the platform 12 which connect with other grooves or recesses,such as recessed area 60, formed in the exterior surfaces of the tibialinsert 210. As such, the hollow rod 250 provides an opening or means forinjecting bone cement 286 into an interior portion of the tibial insert210. The interior channels 256, therefore, operate as a means for movingbone cement 286 from a single point of entry to various other areas ofthe tibial insert 210 which may benefit from the addition of bone cement286. For example, the tibial insert 210 may include various externalspaces, recesses, pockets, or grooves formed within the outer surfacesof the platform 12 and/or the keel 16 to and defined between such outersurfaces and a portion of the patient's tibia 22 into which the insert10 has been implanted. Filling these spaces with bone cement 286provides an additional attachment point between the tibial insert 210and portions of the patient's surrounding tibia 22. In addition toproviding a means or entry point for injecting bone cement 286 in thetibial insert 210, the hollow rod 250 and bone cement 286 also operateto stiffen or reinforce the keel 16 once the bone cement 285 hardens.

Looking now to FIGS. 8-10, there is shown another tibial insert 310 thatis somewhat similar to the tibial inserts 10, 110, 210 described above.As such, like reference numerals have been used in FIGS. 8-10 todesignate features which are similar to those designated in FIGS. 1-7.Illustratively, the keel 16 of the tibial insert 310 illustrativelyincludes two lateral bores 312, 314 formed therethrough. That is, thebores 312, 314 each extend laterally across the keel 16 the medialsurface 140 to the lateral surface 142 of the keel 16. The bores 312,314 are spaced-apart from each other along the anterior-posterior lengthof the keel 16 such that one bore 312 is positioned within a posteriorhalf of the keel 16 while the other bore 314 is positioned within ananterior half of the keel 16.

Illustratively, while two bores 312, 314 are shown, it is within thescope of this disclosure to include a keel 16 having only one bore or toinclude a keel 16 having more than two bores. Further, any lateral boreor bores of the keel 16 may be positioned at any location along theanterior-posterior length of the keel 16. Further, any lateral bore orbores of the keel 16 may be positioned at any location along the heightH of the keel 16. Illustratively, the bores 312, 314, of the keel 16 areshown to be generally centered between the bottom surface 18 of theplatform 12 and the distal surface 144 of the keel 16. Furtherillustratively, an axis (not shown) through each of the bores 312, 314is generally perpendicular to the longitudinal axis of the keel 16 andis generally parallel to the lateral axis 13 of the keel 16. However,the lateral bores 312, 314 may have a non-parallel relationship with thelateral axis 13 of the keel 16 as well.

Illustratively, as noted above, the bores 312, 314 extend from themedial surface 140 of the keel 16 to the lateral surface 142 of the keel16. In other words, the bores 312, 314 extend through the width W of thekeel 16. It is within the scope of this disclosure, however, for anylateral bore formed in the keel 16 to define a blind bore which extendsonly partially through the keel 16. In other words, one such blind boremay be formed in the medial surface 140 of the keel 16 whereas anotherblind bore may be formed in the lateral surface 142 of the keel 16. Assuch, any lateral bore formed in the keel 16 may extend partially orwholly through the width of the keel 16.

Looking now to FIG. 10, during a total or partial knee arthroplasty, asurgeon may resect at least a portion of a condyle to create thesurgically-prepared, generally horizontal surface 280 and thesurgically-prepared, generally vertical surface 282, as discussed abovewith respect to FIG. 7. The surgeon may then form the slot 284 in thesurgically-prepared horizontal surface 280 for receiving the keel 16 ofthe tibial insert 310 therein. Once the slot 284 is formed, the keel 16of the tibial insert 310 is inserted into the slot 284. A fastener 330may then be inserted in a medial-lateral direction through one or moreof the bores 312, 314 of the keel 16 to further secure the keel 16 ofthe tibial insert 310 to the surrounding bone 22. The fastener 330 maybe a rod (as shown in FIG. 10) or a screw, for example.

Prior to inserting the fastener 330 through the bores 312, 314 of thetibia 22, the surgeon may pre-drill a medial-lateral passageway 332through the tibia 22. Such passageway 332 may illustratively extend fromeither the medial or lateral outer surface of the condyle, through theslot 284 formed in the horizontal surface 280 of the condyle and into atleast a portion of the patient's bone on the other side of the slot 284formed in the resected surface. In such a scenario, the passageway 332may be drilled either before or after the keel 16 of the tibial insert310 has been positioned within the slot 284. Once the passageway hasbeen formed and the keel 16 of the tibial insert 310 is properlypositioned within the slot 284, the surgeon may then insert thefasteners 330 within the pre-drilled passageways to further secure thetibial insert 310 to the patient's tibia 22. The surgeon may also chooseto inject bone cement into any pre-drilled passageways prior topositioning the fasteners 330 within the passageways 332. It is, ofcourse, within the scope of this disclosure for the surgeon to simplydrill a screw or other fastener into the resected condyle forpositioning through the bores 312, 314 of the keel 16 without the needto pre-drill any passageway.

Once the fasteners have been properly positioned through the bores ofthe keel 16, any portion of the passageway 332 not containing thefastener 330 may be filled with bone cement. Further, in situationswhere both medial and lateral unicompartmental tibial inserts areimplanted into the same tibia, for example, a single fastener, the sameas or similar to the fastener 330, may be provided for positioningthrough a bore of the keel of each separate tibial insert. In otherwords, a single fastener may be used to secure or anchor two separateunicompartmental inserts to the patient's tibia. Still further, it iswithin the scope of this disclosure to insert a fastener, such asfastener 330, through the bore of two or more keels of a common tibialinsert.

It is also important to note that the bores 312, 314 of the tibialinsert 310 may be used during the manufacturing process of the tibialinsert 310. Illustratively, the bores 312, 314 may be molded into thetibial insert 310 or may be drilled or machined into or through the keel16 after the tibial insert 310 has been molded. After the moldingprocess, a surface treatment or surface coating is often applied to theexternal surfaces of a tibial insert. Such surface coatings includethose described in U.S. Pat. No. 6,736,849, for example, the disclosureof which is hereby incorporated by reference herein. Of course, oneskilled in the art can appreciate that other types of surface coatingsmay be applied to the exterior or outer surfaces of the tibial insert aswell.

Oftentimes, during the surface coating process, a portion of the tibialinsert is masked off in order to be held or grasped by some mechanicalhandler (not shown) such as a chuck or vice, for example. As such, thismasked-off portion of the tibial insert does not receive the surfacecoating or surface treatment. With the tibial insert 310, however, a rodor rods such as rod 330 may be placed into or through the bore or bores312, 314 of the keel 16 as shown in FIG. 9. As noted above, the bores312, 314 may extend entirely or partially through the width of the keel16 to receive the rod(s) therein. In embodiments where the bores onlyextend partially through the keel 16, the mechanical handler itself orthe rod(s) may be inserted into the partial bore or bores to handle andposition the tibial insert without touching or engaging any portion ofthe outer surfaces of the tibial insert. Such rod(s) may then be graspedby the mechanical handler (or a technician) during the surface coatingprocess such that no portion of the mechanical handler is engaged withthe tibial insert. Once the surface coating process is completed, therods 330 may be removed from the tibial insert 310. Because this processdoes not require any portion of the tibial insert 310 to be masked-offand/or grasped, all external surfaces of the tibial insert 310 areunimpeded or exposed and available to be treated or coated with thesurface coating thus increasing the total surface area of the tibialinsert 310 which receives the surface coating.

Looking now to FIGS. 11-14, alternative tibial inserts 410, 510, 610,710 are provided that are somewhat similar to the tibial inserts 10,110, 210, 310 described above. As such, like reference numerals havebeen used in FIGS. 11-14 to designate features which are similar tothose designed in FIGS. 1-10. However, the tibial inserts 410, 510, 610,710 each include a plurality of keels extending downwardly from theplatform.

Looking first to FIG. 11, for example, the tibial insert 410 includesthree keels 416, 418, 420. Illustratively, a longitudinal axis 421 ofthe keel 416 is parallel to a longitudinal axis 423 of the keel 420while a longitudinal axis 425 of the keel 418 is generally orthogonal toboth the longitudinal axes 421, 423 of the keels 416, 420. Further, noneof longitudinal axes 421, 423, 425 of the three keels 416, 418, 420 areparallel to a plane running along the inboard surface or edge 21 of theplatform 12. To compare, the longitudinal axis of the keel of the tibialinserts shown in FIGS. 1-10 is generally parallel to a plane runningalong the inboard surface 21 of the platform 12. Further, the keels 416,418, 420 of the tibial insert 410 shown in FIG. 11 are not coalignedwith each other. In other words, the longitudinal axes of the threekeels 416, 418, 420 do not form a single imaginary line running throughall three keels 416, 418, 420.

Illustratively, the tibial insert 410, as with any tibial insertdisclosed herein, may be divided into sections to generally define ananterior half or side 430 of the tibial insert 410 and a posterior halfor side 432 of the tibial insert 410. The tibial insert 410 may also bedivided into sections to generally define a medial half or side 434 ofthe tibial insert 410 and a lateral half or side 436 of the tibialinsert 410. As such, the keels disclosed in FIGS. 1-10 are generallypositioned such that a substantially equal portion or volume of the keelis positioned on the medial half and the lateral half of the tibialinsert. Further, a substantially equal portion or volume of the keelsdisclosed in FIGS. 1-10 is positioned on the anterior half and theposterior half of the tibial insert.

Looking now to FIG. 11, however, the keels 416 and 420 are generallypositioned within the medial half 434 of the tibial insert 410 whereasthe keel 418 is generally positioned within the lateral half 436 of thetibial insert. Further, the keel 416 is generally positioned within theanterior half 430 of the tibial insert 410 while the keel 420 isgenerally positioned within the posterior half 432 of the tibial insert410. The volume of each of the three keels 416, 418, 420 may be combinedto arrive at a total keel volume of the tibial insert 410. As such, aportion of the total keel volume of the tibial insert 410 which ispositioned within the medial half 434 of the tibial insert 410 isgreater than a portion of the total keel volume which is positionedwithin the lateral half 436 of the tibial insert 410.

Looking now to FIG. 12, the tibial insert 510 also includes three keels516, 518, 520 coupled to the platform 12 and extending downwardly fromthe bottom surface 18 of the platform 12. The keels 516, 518, 520 arearranged such that the longitudinal axes 522, 524, 526 of all threekeels 516, 518, 520 intersect each other. Further, the longitudinal axes522, 526 of the keels 516 and 520 are orthogonal to each other while thelongitudinal axis 524 of the keel 518 bisects the longitudinal axes 522,526 of the keels 516 and 520. Illustratively, the longitudinal axis 524of the keel 518 is generally orthogonal to a plane running along theinboard edge 21 of the platform 12. Similar to the keels 416, 418, 520of the tibial insert 410, the longitudinal axes 526, 518, 520 of thekeels 516, 518, 520 of the tibial insert 510 are not co-aligned witheach other.

In regards to the orientation of the keels 516, 518, 520 of the tibialinsert 510, the keel 518 is generally positioned within the lateral half436 of the tibial insert 510 and is generally centered between theanterior half 430 of the tibial insert 510 and the posterior half 432 ofthe tibial insert 510. The keel 516 is generally located within theanterior half 430 of the tibial insert 510 while the keel 520 isgenerally located within the posterior half 432 of the tibial insert510. Further, a portion of the total keel volume of the tibial insert510 which is positioned within the medial half 434 of the tibial insert510 is greater than a portion of the total keel volume which ispositioned within the lateral half 436 of the tibial insert 510.

Looking now to FIG. 13, the tibial insert 610 includes two keels 616,618. Illustratively, the longitudinal axes 620, 622 of the keels 616,618 are parallel to each other. The keels 616, 618 (and thus thecorresponding longitudinal axes 620, 622 of the keels 616, 618) are notco-aligned with each other along a common axis. Further, the keel 616 isgenerally positioned within an anterior half 430 of the tibial insert610 while the keel 618 is generally positioned within a posterior half432 of the tibial insert 610. Further, both keels 616, 618 are generallypositioned at least mostly within the medial half 434 of the tibialinsert 610. As such, a portion of the total keel volume of the tibialinsert 610 which is positioned within the medial half 434 of the tibialinsert 610 is great than any portion of the total keel volume which ispositioned within the lateral half 436 of the tibial insert 610.

Looking now to FIG. 14, the tibial insert 710 includes two keels 716,718. Illustratively, the longitudinal axes 720, 722 of the keels 616,618 are orthogonal to each other. Further, the keel 716 is generallypositioned within an anterior half 430 of the tibial insert 710 whilethe keel 618 is generally positioned within a posterior half 432 of thetibial insert 710. Further, both keels 716, 718 are generally positionedat least mostly within the medial half 434 of the tibial insert 710. Assuch, a portion of the total keel volume of the tibial insert 710 whichis positioned within the medial half 434 of the tibial insert 710 isgreater than any portion of the total keel volume which is positionedwithin the lateral half 436 of the tibial insert 710. Further, the keels716, 718 (and thus the longitudinal axes 720, 722 of the keels 716, 718)are not co-aligned with each other along a common longitudinal axis.

The tibial inserts 410, 510, 610, 710 shown in FIGS. 11-14 are meant tobe merely illustrative of various tibial inserts having multiple keelsand keel arrangements. It is within the scope of this disclosure toinclude other tibial inserts having any number of keels arranged in anyparticular manner. In other words, it is within the scope of thisdisclosure to include tibial inserts having keel arrangements wherein amajority of the total keel volume is located in either the medial half434 of the tibial insert, the lateral half 436 of the tibial insert, theanterior half 430 of the tibial insert, or the posterior half 432 of thetibial insert. Further, it is within the scope of this disclosure forthe keels to be oriented in various positions. For example, one or morekeels may have a longitudinal axis that is parallel to the inboard edge21 of the tibial insert, orthogonal to the inboard edge 21 of the tibialinsert, or simply angled or non-parallel to the inboard edge 21 of thetibial insert. It is also within the scope of this disclosure to includekeel arrangements having keels of different sizes or dimensions (length,width, and height) than those shown in FIGS. 11-14.

Providing tibial inserts having a wide variety of keel arrangementsprovides a surgeon with a number of options in choosing which particulartibial insert is most appropriate for the particular patient undergoingTKA or UKA. The term “keel arrangement” refers to the number andorientation of the keels on the tibial insert. In any event, a surgeonperforming a TKA or UKA typically begins the procedure by resecting atleast one condyle of the patient's tibia. Once the condyle is resected,the surgeon may evaluate and assess the quality of the remaining bone.In particular, resecting the condyle forms a generally horizontalsurgically-prepared surface such as surface 280 noted above with regardto FIGS. 7 and 10. The surgeon may evaluate the quality of the patient'sbone within this surface. Such an assessment may be fairly subjective tothe surgeon. In any event, it is oftentimes preferable to keep orpreserve as much “good” quality bone as possible while removing any andall “poor” quality bone. Oftentimes, the “good” quality bone is locatedwhere the keel of a typical tibial insert is to be implanted. In suchsituations, the surgeon is forced to remove this good quality bone tocreate a slot or bore for receiving the keel of the particular tibialinsert to be implanted.

The present disclosure, however, contemplates a variety of tibialinserts available to the surgeon which include a variety of keelarrangements. During surgery, therefore, the surgeon may assess thequality of the patient's bone after the tibia has been resected tocreate the surgically-prepared, horizontal surface. The surgeon may thennote any areas of this surgically-prepared surface of the patient's bonewhich include “good” or “poor” bone quality. Illustratively, a template,such as the template 1010 shown in FIG. 20 may be used by the surgeon toaide the surgeon in assessing the quality of the exposed bone.

Looking in particular to FIG. 21, the template 1010 includes a handle1012 and a platform 1014 coupled to the handle and shaped for use orplacement on a surgically-prepared, horizontal surface of a resectedtibia. Illustratively, the platform 1014 includes a first slot orcut-out portion 1016 and a second slot or cut-out portion 1018 smallerthan and parallel to the first slot 1016. The first slot 1016 and thesecond slot 1018 correspond to a particular keel arrangement of a tibialinsert 810 shown in FIGS. 15-19 (discussed in greater detail below). Assuch, the template 1010 includes cut-out portions 1016, 1018 whichrepresent a single keel arrangement for a single tibial insert. As such,many various templates may be provided which each include cut-outportions representative of a single keel arrangement of a particulartibial insert. Alternatively, the template 1020 includes an array ofcut-out portions 1022 formed through the platform 1014. This array ofcut-out portions 1022 may permit the surgeon to assess the quality ofvarious areas of the exposed tibia bone not necessarily associated withthe keel arrangement of one particular tibial insert in order todetermine which tibial insert from a variety of tibial inserts is bestrepresentative of the areas of poor bone quality.

During surgery, for example, the surgeon may place one of the templates1010, 1020 over the horizontal, surgically-prepared surface of the tibiaand may use a probe to check various areas of the horizontal tibialsurface to assess the softness or quality of these areas of the bone.For example, when using the template 1010, the surgeon may insert theprobe through the cut-out portions 1016 and 1018 to check these areas ofthe bone and determine whether the tibial insert having a keelarrangement corresponding to these cut-out portions is appropriate.Alternatively, when using the template 1020, the surgeon may probe thebone exposed through the various cut-out portions 1022 to determinewhich areas of the tibia are of poor bone quality. Illustratively, eachcut-out portion 1022 may correspond to a possible anterior end orposterior end of a keel such that once a surgeon determines where areasof poor bone quality exist, a closest corresponding keel arrangement ofa particular tibial insert may be determined.

The surgeon may mark on either the patient's bone or on whichevertemplate 1010 or 1020 is used in such a way as to indicate areas of thetibial surface having good and/or poor bone quality. In either case,once the quality of the bone of the horizontal surface has beenassessed, the surgeon may then select a tibial insert from the varietyof tibial inserts provided which includes a keel arrangement mostclosely corresponding to the poor bone quality areas of thesurgically-prepared surface. Of course, it is within the scope of thisdisclosure to include various other template devices having any numberof cut-out portions which permit a surgeon to probe thesurgically-prepared, horizontal surface of the tibia through suchcut-out portions in order to determine the quality of the bone.

Once the appropriate tibial insert has been chosen, the surgeon thenforms or creates a slot or slots in the surgically-prepared surfacewhich correspond to the keel arrangement of the tibial insert which hasbeen chosen. For example, if the surgeon were to choose the tibialinsert 410 shown in FIG. 11, the surgeon would then drill three slots ofthe same size and orientation as the keels 416, 418, 420 of the tibialinsert 410 into the generally horizontal, surgically-prepared surface.The template used by the surgeon may be left in-place on the horizontalsurgically-prepared tibial surface to assist the surgeon in determiningwhere to create the slot or slots. Once the appropriate slots arecreated, the surgeon may then implant the tibial insert by inserting thekeels of the tibial insert into the corresponding slots. It is alsowithin the scope of this disclosure to fill each slot with bone cementto further secure the tibial insert to the patient's tibia.

By providing multiple tibial inserts having multiple keel arrangements,a surgeon is better able to customize the tibial insert to the patient.The surgeon is able to choose a tibial insert which allows him to removeareas of poor quality bone while maintaining or preserving as much goodquality bone as possible. Further, a tibial insert having multiple keelsmay operate to increase the rigidity and fixation of the tibial insertwithin the patient's bone. Further, a tibial insert having multiplekeels may also operate to prevent rotational movement of the implantedtibial insert relative to the patient's tibia. As noted above, it iswithin the scope of this disclosure to include other tibial insertshaving other keel arrangements than those disclosed in FIGS. 11-14.

Looking now to FIGS. 15-19, there is shown a tibial insert 810 that issomewhat similar to the tibial inserts described above. As such, likereference numerals have been used in FIGS. 15-19 to designate featureswhich are similar to those designated in FIGS. 1-14. Illustratively, thekeel 16 of the tibial insert 810 includes an angled or chamferedanterior surface 834 and a flat or generally vertical posterior surface836. The angle of the anterior surface 834 is approximately 55 degreesfrom vertical (or 145 degrees from the bottom surface 18 of the platform12). However, it is within the scope of this disclosure to include ananterior surface being angled to any suitable degree from vertical.Further still, the anterior surface 834 may be generally vertical, orperpendicular to the bottom surface 18 of the platform 12.

The tibial insert 810 further includes a second keel 816 spaced-apartfrom the first keel 16. As shown in FIG. 15, the second keel 816 isshorter than the first keel 16. Similar to the first keel 16, however,the second keel 816 includes an angled or chamfered anterior surface 840and a generally vertical posterior surface 842. Illustratively, theangle of the anterior surface 840 of the second keel 816 isapproximately 55 degrees from vertical. However, it is within the scopeof this disclosure to include an anterior surface being angled to anysuitable degree from vertical. Illustratively, the angle of the anteriorsurface 840 may be between approximately 100-155 degrees from the bottomsurface 18 of the platform 12. Further, in some preferred embodiments,the angle may be between approximately 130-145 degrees from the bottomsurface of the platform.

Further, illustratively, the anterior surface 840 of the second keel 816is positioned posteriorly from the anterior surface 834 of the firstkeel 16. As such, the second keel 816 provides a posterior fixationfeature of the tibial insert 810. A posterior fixation feature such asthe second keel 816 provides additional posterior support of the tibialinsert 810. For example, as a patient's knee is bent, the patient'sfemur or a femoral component (not shown) moves posteriorly on thebearing surface 14. A posterior fixation feature, such as the secondkeel 816, provides additional support in such instances to bettertransmit load from the patient's femur to the patient's tibia. Theangled anterior surface 840 of the second (or posterior) keel 816 allowsthe keel to be positioned further posteriorly than a same or similarkeel having a generally vertical anterior surface. Illustratively,therefore, increasing the angle of the anterior surface 840 of thesecond keel 816 allows the second keel 816 to continue to be positionedfurther posteriorly relative to the platform 12 from which the keel 16extends. Further, reducing the height of the second keel 816 also allowsthe second keel 816 to be positioned further posteriorly on the platform12 while maintaining the minimally invasive approach for implanting suchan insert 810.

As noted above, a minimally invasive approach for implanting such tibialinserts provides for an angled-entry approach due to the minimalclearance provided between the patient's femur and the patient's tibia.As such, the angled anterior surface 840 of the second, posterior keel816 (as well as the angled anterior surface 834 of the first keel 16)allows the tibial insert 810 to be inserted at an angle and thengenerally pivoted into place. The angled anterior surfaces 834 and 840provide sufficient clearance from the anterior ends 860, 882 of therespective first and second slots 850, 880 to make the angled-entryfeasible.

Looking now to FIG. 16, a patient's tibia 22 has been resected to createthe surgically-prepared, horizontal surface 280 and thesurgically-prepared, vertical surface 282. These surgically-preparedsurfaces 280, 282 may be prepared using standard surgical techniques.Further, such surfaces 280, 282 may also be prepared by those techniquesdisclosed and discussed in U.S. patent application Ser. No. 11/171,802filed on Jun. 30, 2005.

In any event, once the tibia has been resected, a first slot 850 isformed in the surgically-prepared, horizontal surface 280. The firstslot 850 is sized and positioned to receive the first keel 16 of thetibial insert 810 therein. As shown in FIG. 16, the first slot 850 isgenerally centrally located in an anterior-posterior direction and doesnot extend to either the anterior surface 852 of the resected tibia 22or the posterior surface 854 of the resected tibia 22. In other words,an anterior end 860 of the first slot 850 is spaced-apart from theanterior surface 852 of the patient's tibia 22. Similarly, a posteriorend 862 of the slot first 850 is spaced-apart from the posterior surface854 of the patient's tibia 22.

A second slot 880 is also formed in the surgically-prepared, horizontalsurface 280. The second slot 880 is sized and positioned to receive thesecond keel 816 of the tibial insert 810 therein. As shown in FIG. 16,the second slot 880 is spaced-apart in a lateral direction from thefirst slot 850 and similarly does not extend to either the anteriorsurface 852 of the resected tibia 22 or the posterior surface 854 of theresected tibia 22. Further, an anterior end 882 of the second slot 880positioned posteriorly from the anterior end 860 of the first slot 850.Similar to the first slot 850, both the anterior end 882 and a posteriorend 884 of the second slot 880 are spaced-apart from the anterior andposterior surfaces 852,854 of the patient's tibia 22.

The first and second slots 850, 880 may be formed by punching orcompressing an outline of the shape of the slot into thesurgically-prepared horizontal surface 280 of the tibia 22 and thenraking away the cut-out portion of the bone. Further, such slots 850,880 may be formed by 90 degree milling or by using a bone drill atmultiple angles and positions. Further, a drill may be used to form ananterior hole and a posterior hole in the surgically-prepared surface280 of the tibia 22. Once the anterior and posterior holes are formed,the bone between the two holes may be raked away to create the necessaryslot. Other method or techniques known to those skilled in the art mayalso be used to form slots such as the first and second slots 850, 880described herein.

Looking now to FIG. 17, the posterior end 836 of the first keel 16 ofthe tibial insert 810 is positioned within the first slot 850 formed inthe horizontal, surgically-prepared surface 280. Further, the posteriorend 842 of the second keel 816 of the tibial insert 810 is positionedwithin the second slot 880 formed in the tibial surface 280. The surgeonmust angle the tibial insert 810 relative to horizontal such that theposterior end of the tibial insert 810 is generally angled downwardly inorder to insert the posterior end 836 of the first keel 16 into thefirst slot 850 and to insert the posterior end 842 of the second keel816 into the second slot 880.

The degree of angle of this entry may vary depending on the surgeon'sparticular style or technique and may further depend upon the clearanceprovided between the tibia 22 and the patient's femur 23. This angledinsertion may provide a less invasive means of implanting the tibialinsert 810 into the tibia 22 in cases where the slot or slots providedto receive the keel(s) of the tibial insert do not extend to theanterior surface 852 of the tibia 22. Further, sizing the slot(s) formedin the surgically-prepared surface 280 to correspond to the size of thekeel(s) to be inserted therein reduces the amount of bone the surgeonmust remove from the patient's tibial 22.

The posterior ends 836, 884 of the first and second keels 16, 816generally remain within the respective first and second slots 850, 880while the surgeon slides the tibial insert 810 posteriorly. Once theposterior end 836 of the first keel 16 is inserted into the first slot850 and the posterior end 842 of the second keel 816 is inserted intothe second slot 880, the tibial insert 810 is moved or slid posteriorlyuntil the posterior end 836 of the first keel 16 engages the posteriorend 862 of the first slot 850 and the posterior end 840 of the secondkeel 816 engages the posterior end 884 of the second slot 880, as shownin FIG. 18. Once the posterior ends 836, 884 of the first and secondkeels 16, 816 have engaged the respective posterior ends 862, 884 of thefirst and second slots 850, 880, the surgeon pushes the anterior end ofthe tibial insert 810 downwardly or in an inferior direction until thekeels 16, 816 are completely received within their respective slots 850,880, as shown in FIG. 19.

The angled anterior surfaces 834, 840 of the first and second keels 16,816 provide clearance for the anterior portion of the keels 16, 816 asthe tibial insert 810 is generally pivoted downwardly into place withinthe slots 850, 880. In other words, the angled anterior ends 834, 840 ofthe first and second keels 16, 816 allows the surgeon to insert thetibial insert 810 at an angle (to reduce the amount of clearancenecessary between the patient's tibia and femur) and then pivot thetibial insert 810 downwardly rather than requiring the surgeon toposition the tibial insert directly above the slot such that the keeland the slot are aligned with each other, to then uniformly lower thekeel of the tibial insert into the slot. As such, the present techniqueprovides a more minimally-invasive approach which does not require asgreat a clearance or space between the tibia and the femur. Further, aslot or slots which do not extend to either the anterior or posteriorsurfaces of the tibia are smaller than slots which do extend to one orboth of the anterior or posterior surfaces of the tibia. As such,creating a smaller slot, such as the slots 850, 880 shown in FIGS.16-19, allows the surgeon to remove less bone from the patient's tibiaand, therefore, allows the surgeon to preserve as much of the patient'sown bone as possible.

Illustratively, the tibial inserts 10, 110, 210, 310, 410, 510, 610,710, and 810 disclosed herein may include platforms having a skirtoverlay such that portions of the platform may lay over and adjacent theouter surface of the tibia of the patient, for example. Further, thetibial inserts 10, 110, 210, 310, 410, 510, 610, 710, and 810 mayinclude inlay portions coupled to the platform and/or keel of therespective inserts which lay into the surgically-prepared horizontaland/or surgically-prepared vertical surfaces of the tibia.

Further illustratively, the platform and keel portions of the tibialinserts 10, 110, 210, 310, 410, 510, 610, 710, and 810 disclosed hereinare made from a polyethylene and may be made from UHMWPE (ultra-highmolecular weight polyethylene), for example. However, the tibial inserts10, 110, 210, 310, 410, 510, 610, 710, and 810 may also be made fromother materials suitable for implantation into the human body. As notedabove, the rods 50, 150, and 250 of the tibial inserts 10, 110, and 210are illustratively made from a metal such or metal substrate such astitanium, stainless steel, or cobalt chromium, for example. However,such rods 50, 150, 250 may be made from other suitable metals as well.Further, such rods 50, 150, 250 may be made from one or more materialsother than metals such as polymers, ceramics, cements, glass, etc.

Further, although the tibial inserts 10, 110, 210, 310, 410, 510, 610,710, and 810 of the present disclosure are shown and described asunitary or monolithic components, it is within the scope of thisdisclosure to include tibial inserts having multiple components. Forexample, a tibial insert of the present disclosure may include a traycomponent and a bearing component molded to the tray or separate fromthe tray for cooperation with the tray. Either the tray component or thebearing component may be made from metal, polyethylene, and/or acombination of metal and polyethylene. Illustratively, therefore, theterm tibial insert hereby includes both unitary tibial inserts andtibial inserts having separate tray and bearing components.

While the concepts of the present disclosure have been illustrated anddescribed in detail in the drawings and foregoing description, such anillustration and description is to be considered as exemplary and notrestrictive in character, it being understood that only the illustrativeembodiments have been shown and described and that all changes andmodifications that come within the spirit of the disclosure are desiredto be protected.

There are a plurality of advantages of the present disclosure arisingfrom the various features of the apparatus and methods described herein.It will be noted that alternative embodiments of the apparatus andmethods of the present disclosure may not include all of the featuresdescribed yet still benefit from at least some of the advantages of suchfeatures. Those of ordinary skill in the art may readily devise theirown implementations of an apparatus and method that incorporate one ormore of the features of the present disclosure and fall within thespirit and scope of the present disclosure.

The invention claimed is:
 1. A tibial insert comprising: a platform including an upper bearing surface, a keel extending downwardly from the platform, the keel having (i) a body formed from a first material and including a medial, downwardly-extending surface that defines a medial side of the keel, a lateral, downwardly-extending surface that defines a lateral side of the keel, and a distal surface connecting the medial, downwardly-extending surface and the lateral, downwardly-extending surface, (ii) a length defined along a longitudinal axis, and (iii) a width defined between the medial, downwardly-extending surface and the lateral, downwardly-extending surface along a lateral axis extending orthogonal to the longitudinal axis, and a reinforcement rod secured to the keel and formed from a second material different from the first material, wherein the keel includes a first opening defined in the medial, downwardly-extending surface, a second opening defined in the lateral, downwardly-extending surface, and a lateral bore extending between the first opening and the second opening transverse to the length of the keel and entirely through the width of the keel from the medial side to the lateral side, wherein the reinforcement rod is positioned in the lateral bore, the reinforcement rod extending from a first end positioned in the first opening of the keel to a second end positioned in the second opening of the keel such that the reinforcement rod extends entirely through the width of the keel from the medial side to the lateral side of the keel, and the reinforcement rod has a rod length extending from the first end of the reinforcement rod to the second end of the reinforcement rod, the rod length being equal to the width of the keel.
 2. The tibial insert of claim 1, wherein the lateral bore is parallel to the lateral axis of the keel.
 3. The tibial insert of claim 1, wherein the distal surface is a rounded, distal surface defining a continuous radius connecting the medial, downwardly-extending surface and the lateral, downwardly-extending surface.
 4. The tibial insert of claim 3, wherein the lateral bore is substantially centrally-located between a bottom surface of the platform and the rounded, distal surface of the keel.
 5. The tibial insert of claim 1, wherein the lateral bore is substantially parallel with the platform.
 6. The tibial insert of claim 1, wherein the lateral bore has a circular cross-section.
 7. The tibial insert of claim 1, wherein the reinforcement rod has a rod axis extending through the first end and the second end thereof, and the rod axis extends parallel to the lateral axis of the keel. 